NL-OMON52660
Recruiting
Not Applicable
Clinical trial to evaluate safety and efficacy of the C2 CryoBalloon 180° Ablation System for the treatment of dysplastic Barrett*s esophagus: CBAS180 de-escalation study - CBAS180 de-escalation study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Barrett's esophagus
- Sponsor
- Pentax Medical
- Enrollment
- 122
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Flat type BE esophagus, with an indication for ablation therapy, defined as:
- •a) Diagnosis of LGD or HGD in BE (confirmed by BE expert pathologist) or;
- •b) Residual BE with any grade of dysplasia after endoscopic resection (by means
- •of EMR or ESD) to treat non\-flat BE, \>\=6 weeks prior to enrolling the patient to
- •this study. The ER pathology should indicate endoscopic treatment (i.e. only
- •mucosal invasion or limited submucosal invasion (sm1\), no lymphovascular
- •infiltration, free vertical resection margins and not poorly differentiated).
- •2\) Prague Classification Score of C\<\=3 and M\>\=1\.
- •3\) Patients should be ablation\-naïve, meaning they have not undergone any
- •previous endoscopic ablation therapy of the esophagus.
Exclusion Criteria
- •1\) Esophageal stenosis preventing advancement of a therapeutic endoscope.
- •2\) Any endoscopically visualized lesion such as ulcers, masses or nodules.
- •Neoplastic nodules must first be treated with ER \>\=6 weeks prior to planned
- •treatment under this protocol.
- •3\) Prior ER of \>2cm in length and/or \>50% of the esophageal lumen
- •circumference.
- •4\) History of locally advanced (\>sm1\) esophageal cancer.
- •5\) History of esophageal varices.
- •6\) Prior distal esophagectomy.
- •7\) Active esophagitis LA grade B or higher.
Outcomes
Primary Outcomes
Not specified
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